FDA.report

ECOHF-GRIP

Primary DI
04048223084847
Brand
ECOHF-GRIP
Company
Pajunk GmbH Medizintechnologie
Model
2002-00-00
Catalog number
2002-00-00
Device description
2002-00-00
Published
2021-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048223034330PreviousGS10
04048223084847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048223034330040482230343304048223034330
04048223084847040482230848474048223084847

GMDN Terms

TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 770-493-6832info@pajunk-usa.com

Regulatory Flags

DUNS number
317654283
Device count
1
DM exempt
true
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
true

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04048223128817SPROTTE®511151-29A511151-29A2025-09-16
04048223129111SPROTTE® NRFit051163-29A051163-29A2025-09-16
04048223129517SPROTTE® NRFit041163-29A041163-29A2025-09-16
04048223129647SPROTTE®071151-30C071151-30C2025-09-16
04048223129678SPROTTE® NRFit021163-30C021163-30C2025-09-16
04048223129692SPROTTE® NRFit031163-27A031163-27A2025-09-16
04048223129838SPROTTE® NRFit061163-29A061163-29A2025-09-16
04048223129999Standard Sprotte Needle321151-29A321151-29A2025-09-16
04048223131398Standard Sprotte Needle341151-31B341151-31B2025-09-16
04048223131428SPROTTE®131151-30C131151-30C2025-09-16
04048223131442SPROTTE®131151-30A131151-30A2025-09-16
04048223131466SPROTTE®141151-30C141151-30C2025-09-16
04048223132050SonoPlex® II Facet S001287-72001287-722025-09-16
04048223132135SonoPlex® II Facet S001287-76001287-762025-09-16
04048223132241SonoPlex® II Facet NRFit001265-74001265-742025-09-16
04048223132319SonoPlex® II Facet NRFit001265-77001265-772025-09-16
04048223132395SonoPlex® II Facet001285-76001285-762025-09-16
04048223132463SonoBlock II Facet001280-74001280-742025-09-16
04048223132562SonoPlex® II Facet S NRFit001267-76001267-762025-09-16

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776417895MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418298MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418304MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418311MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00817428021551ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
10817428021558ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
00198506089527ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-13
10649111501326Sklar InstrumentsSKLAR CORPORATIONGCJ2026-03-12
00190776417840MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417857MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417864MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417888MillenniumAvalign Technologies, Inc.GCJ2026-03-11
B382SD4387110Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
B382SD481753PTSTR0Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
B382SD4817570Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
B382SD4817590Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
00198506088964ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
00198506089060ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
00198506089077ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
00198506089084ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
B382SD56534910Surgical DirectSurgical Direct, Inc.GCJ2026-03-02
B382SD56740240Surgical DirectSurgical Direct, Inc.GCJ2026-03-02
B382SD76500310Surgical DirectSurgical Direct, Inc.GCJ2026-03-02
04251303824985BLUEENDOTROKAMED GmbHGCJ2026-02-27
00198506088704ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-25
00198506088711ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-25
00198506088216ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23
00198506088438ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23
00198506088483ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23
00198506088490ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23