FDA.reportPublic FDA data

N/A

Primary DI
00885825013370
Brand
N/A
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
N/A
Catalog number
5DSG
Device description
Endopath Grasper w/Ratchet Handle
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWVLaparoscopic accessories, gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30885825013371PackageGS16In Commercial Distribution
00885825013370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088582501337130885825013371
00885825013370008858250133708858250133700885825013370

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic tissue manipulation forceps, reprocessedA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a previously used single-use device that has been processed for an additional single-use patient application.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-22 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(888)888-3433RegulatoryAffairs2@stryker.com

Regulatory Flags#

DUNS number
020198912
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327688788N/APSCIC101PSCIC1012026-04-06
07613327688764N/AAFR-00006AFR-000062026-02-10
07613327681710N/AR7219-RPR7219-RP2026-02-11
07613327687217N/AM004PF41M444M004PF41M4442025-12-16
07613327688795N/AD133701D1337012025-12-16
00850043377092Aquamantys23-112-123-112-12024-05-16
00850043377085Aquamantys23-313-123-313-12024-05-16
00850043377108Aquamantys23-113-123-113-12024-05-16
07613327682045N/AM004PF41M434M004PF41M4342025-09-29
00885825011703N/AN/A4083092016-09-23
00885825011710N/AN/A4083102016-09-23
00885825011727N/AN/AG4083242016-09-23
07613327663365N/AHAR723HAR7232025-08-27
07613327663389N/AHAR736HAR7362025-08-27
07613327663419N/AHAR745HAR7452025-08-27
37613327663366N/AHAR723HAR7232025-08-27
37613327663380N/AHAR736HAR7362025-08-27
37613327663410N/AHAR745HAR7452025-08-27
07613327487640N/AHM39SPU-HLFHM39SPU-HLF2019-07-10
07613327487671N/AHM50RPSPUHM50RPSPU2019-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421601MillenniumAvalign Technologies, Inc.NWV2026-05-05
00190776421250MillenniumAvalign Technologies, Inc.NWV2026-05-04
00190776421076MillenniumAvalign Technologies, Inc.NWV2026-04-30
00848657078368AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-04-23
00190776420277MillenniumAvalign Technologies, Inc.NWV2026-04-16
00190776418991MillenniumAvalign Technologies, Inc.NWV2026-04-13
00190776418427MillenniumAvalign Technologies, Inc.NWV2026-03-25
00190776418434MillenniumAvalign Technologies, Inc.NWV2026-03-25
00190776418441MillenniumAvalign Technologies, Inc.NWV2026-03-25
00848657078269AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-03-02
00190776417390MillenniumAvalign Technologies, Inc.NWV2026-02-27
00190776417406MillenniumAvalign Technologies, Inc.NWV2026-02-27
00190776417451MillenniumAvalign Technologies, Inc.NWV2026-02-27
00198506088520ELMED INCORPORATEDELMED INCORPORATEDNWV2026-02-23
00190776416072MillenniumAvalign Technologies, Inc.NWV2026-02-06
00190776415631MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415648MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415655MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415402MillenniumAvalign Technologies, Inc.NWV2026-01-27
00848657078108AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657078115AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657078122AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657077958AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00848657077965AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00848657078009AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00198506086489ELMED INCORPORATEDELMED INCORPORATEDNWV2025-11-05
00190776414344MillenniumAvalign Technologies, Inc.NWV2025-10-23
00190776413910MillenniumAvalign Technologies, Inc.NWV2025-10-21
00190776413958MillenniumAvalign Technologies, Inc.NWV2025-10-21
00848657077682AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2025-10-15