FDA.reportPublic FDA data

PILLING

Primary DI
24026704417593
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN004238
Catalog number
200161
Device description
LAMINECTOMY WEDGES STERILE 3/4"X3/8"
Published
2016-09-16
Public version status
Update
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
EFQGAUZE/SPONGE, INTERNAL
GDYGAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704417593PackageGS1200In Commercial Distribution
04026704417599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670441759324026704417593
04026704417599040267044175994026704417599

GMDN Terms#

Term, Definition table
TermDefinition
Woven surgical spongeA non-medicated sterile device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It does not contain special features to help detect gossypiboma (sponge left inside patient). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.75Inch
Width0.375Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
10801902228205ARROWIPNB00283ASK-45703-NCC32026-09-25
10801902228212ARROWIPNB00282ASK-45802-NCC2026-09-25
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902228717ARROWCDA-42703-XPCN1ACDA-42703-XPCN1A2026-09-22
04026704916955RUSCHIPN9007315640002026-08-03
10841156111519TELEFLEXIPN93068158822025-06-12
10841156111540TELEFLEXIPN93068258842025-06-12
10841156111595TELEFLEXIPN93068458882025-06-12
10841156111755TELEFLEXIPN93068358862025-06-12
14026704302182RUSCHIPN0505091807051202016-09-16
14026704302205RUSCHIPN0505111807051402016-09-16
14026704302229RUSCHIPN0505131807051602016-09-16
14026704302243RUSCHIPN0505151807051802016-09-16
14026704302267RUSCHIPN0505171807052002016-09-16
14026704302281RUSCHIPN0505191807052202016-09-16
14026704302304RUSCHIPN0505211807052402016-09-16
14026704302328RUSCHIPN0505231807052602016-09-16
14026704302342RUSCHIPN0505251807052802016-09-16
14026704302366RUSCHIPN0505271807053002016-09-16
14026704302977RUSCHIPN0505911834052002016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536924000BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924024BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924031BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924055BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
10192253047509CurityCardinal Health 200, LLCEFQ2026-04-08
10198956239692CARDINAL HEALTHCardinal Health 200, LLCGDY2025-11-28
00850049994866SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994873SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994880SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994897SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994903SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994910SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994927SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994934SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994941SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994958SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994965SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994972SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994996SynterventionZien Medical Technologies, LLCGDY2025-09-23
00850049994989SynterventionZien Medical Technologies, LLCGDY2025-09-22
07613327465853SurgiCount Safety-SpongeSTRYKER CORPORATIONGDY2025-09-03
10080196717811MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-04-25
10810178830005Tally Surgical SolutionTally Surgical, Inc.GDY2025-02-18
10197106760994CARDINAL HEALTHCardinal Health 200, LLCGDY2025-01-29
10080196031313MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-01-16
10080196743926MEDLINEMEDLINE INDUSTRIES, INC.GDY2024-10-15
10192253047523CurityCardinal Health 200, LLCEFQ2023-10-09
10192253047561CurityCardinal Health 200, LLCEFQ2023-10-09
10326053119504Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119511Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09