SD03816027

GUDID H981SD038160270

9MM SOFT TISSUE RETRACTOR SCOOP

SYNTHES (U.S.A.) LP

Hand-held surgical retractor, reusable
Primary Device IDH981SD038160270
NIH Device Record Keydffab573-60b0-4526-89c9-93e3e3fd061b
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSD03.816.027
Catalog NumberSD03816027
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034705132 [Primary]
HIBCCH981SD038160270 [Secondary]

FDA Product Code

GADRETRACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


[H981SD038160270]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-10-13
Device Publish Date2016-12-31

Devices Manufactured by SYNTHES (U.S.A.) LP

H981PDL432F - NA2026-02-09 INLAY PUSHER-MEDIUM
H981PDL434H - NA2026-02-09 INLAY PUSHER-LARGE
07611819995796 - NA2026-02-09 TAMP
07611819943490 - NA2026-02-09 HEAD IMPACTOR
H679E51157P09 - NA2026-02-09 PLASTIC TIP FOR HEAD IMPACTOR
10886982293060 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 60MM/ XL25
10886982293237 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 30MM/ XL25
10886982293244 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 32MM/ XL25

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.