SD03211116

GUDID 10886982349873

CANNULATED CIRCULAR REAMER 16MM

Synthes GmbH

Bone-resection orthopaedic reamer, reusable
Primary Device ID10886982349873
NIH Device Record Key1db0ffcb-4283-4bb6-800f-373ba3eb4010
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSD03.211.116
Catalog NumberSD03211116
Company DUNS486711679
Company NameSynthes GmbH
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982349873 [Primary]

FDA Product Code

HTOREAMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10886982349873]

Moist Heat or Steam Sterilization


[10886982349873]

Moist Heat or Steam Sterilization


[10886982349873]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-01
Device Publish Date2025-08-22

Devices Manufactured by Synthes GmbH

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10886982351593 - NA2026-02-18 XL25 SOLID SCREWDRIVER 250.5MM LENGTH
10886982362186 - NA2026-01-19 CONNECTOR UNIT RFNA PROXIMAL AIMING DEVICE
10886982362193 - NA2026-01-19 CALIBRATION UNIT RFNA PROXIMAL AIMING DEVICE
10886982362209 - NA2026-01-19 ANGULAR ADJUSTMENT LOCK KNOB RFNA PROXIMAL AIMING DEVICE
10886982362216 - NA2026-01-19 LINEAR ADJUSTMENT LOCK KNOB RFNA PROXIMAL AIMING DEVICE
10886982361257 - VOLT2025-12-24 REPLACEMENT BRKTS F/60.529.005
H9810460002902S0 - NA2025-12-11 TI DISTRACTOR PINS-16MM STERILE

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