FDA.reportPublic FDA data

WAL applicator

Primary DI
14260170880502
Brand
WAL applicator
Company
Human Med AG
Model
Single-use WAL Applicator, Short, L=300, for 20 cm
Catalog number
500001K-5
Device description
WAL applicator, accessory for body-jet; suitable for WAL cannulas (20 cm), Single-use
Published
2025-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QPBSystem, Suction, Lipoplasty For Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPBSystem, Suction, Lipoplasty For RemovalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082025000BODY-JETHuman Med AG2008-08-13QPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14260170880502PackageGS15In Commercial Distribution
04260170880505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1426017088050214260170880502
04260170880505042601708805054260170880505

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration tubing setA collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature8 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature8 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49385395700info@humanmed.com

Regulatory Flags#

DUNS number
332719157
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260170880048WAL applicatorSingle-use WAL Applicator for body-jet, L=300500001-52025-07-30
04260170880505WAL applicatorSingle-use WAL Applicator, Short, L=300, for 20 cm500001K-52025-07-30
04260170880826WAL CannulaSingle-use, Ø=3.8, L=300, 4H, Extraction1500125-52025-07-30
04260170880864WAL CannulaSingle-use, Ø=4.8, L=300, 4H, Extraction1500136-52025-07-30
04260170880888WAL CannulaSingle-use, Ø=4.2, L=300, 4H, Extraction1500148-52025-07-30
04260170880901WAL CannulaSingle-use, Ø=3.8, L=300, 4H, Extraction1501125-52025-07-30
04260170880925WAL CannulaSingle-use, Ø=3.8, L=300, 3H, Extraction, Subcutan1502004-52025-07-30
04260170880949WAL CannulaSingle-use, Ø=3.8, L=300, 8H, Extraction1503004-52025-07-30
04260170880963WAL CannulaSingle-use, Ø=4.8, L=300, 8H, Extraction1503005-52025-07-30
04260170881007Biofill CannulaSingle-use, Ø=3.5, L=150, 4H, Extraction1580089-52025-07-30
04260170881021Biofill Infiltration CannulaSingle-use, Ø=2.5, L=150, 0H, Infiltration1580107-52025-07-30
04260170881045Biofill CannulaSingle-use, Ø=3.8, L=150, 4H, Extraction1580125-52025-07-30
04260170881069Biofill CannulaSingle-use, Ø=3.8, L=150, 4H, Rapid, Extraction1581125-52025-07-30
04260170881083FillerCollectorSingle-use FillerCollector, 250ml, Collect Fat1660000-52025-07-30
04260170881113Q-graft collectorSingle-use Q-graft collector3000012025-07-30
04260170881137WAL Infiltration CannulaSingle-use, Ø=2.5, L=200, 0H, 180°, Infiltration1500114-52025-07-30
04260170881144WAL applicator, 370 cmSingle-use WAL Applicator for body-jet evo, L=370,570001-52025-07-30
04260170881151Biofill applicatorSingle-use Biofill Applicator for body-jet evo and580001-52025-07-30
04260170881373Disposable Set FillerCollectorSingle-use Disposable Set for Re-usable FillerColl6600232025-07-30
04260170881403Disposable Set LipoCollector IIISingle-use Disposable Set for Re-usable LipoCollec6702002025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607151050627AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 3 ringsAPYX MEDICAL CORPORATIONQPB2026-06-26
00607151050634AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 26cm length, 3 ringsAPYX MEDICAL CORPORATIONQPB2026-06-26
00607151050641AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 1 ringAPYX MEDICAL CORPORATIONQPB2026-06-26
00840329838225BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.QPB2026-06-08
00607151051006AYON™ Power Liposuction Tubing AdaptorAPYX MEDICAL CORPORATIONQPB2026-05-14
00607151057008AYON™ Power Liposuction HandpieceAPYX MEDICAL CORPORATIONQPB2026-05-14
00607151057015AYON™ Power Liposuction CableAPYX MEDICAL CORPORATIONQPB2026-05-14
08800028800031LSSA (NP-200)NewpongQPB2026-05-06
03701416200035EUROMIEuromiQPB2025-08-27
03701416203388EUROMIEuromiQPB2025-08-27
03701416203401EUROMIEuromiQPB2025-08-27
00847399017413MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017420MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017437MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017444MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017451MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017468MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017475MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017482MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017499MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017505MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017512MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399018960MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
04260170880048WAL applicatorHuman Med AGQPB2025-07-30
04260170880505WAL applicatorHuman Med AGQPB2025-07-30
04260170880826WAL CannulaHuman Med AGQPB2025-07-30
04260170880864WAL CannulaHuman Med AGQPB2025-07-30
04260170880888WAL CannulaHuman Med AGQPB2025-07-30
04260170880901WAL CannulaHuman Med AGQPB2025-07-30
04260170880925WAL CannulaHuman Med AGQPB2025-07-30