AccessGUDID - DEVICE: NA (10886982077691)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 03.306.002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03306002
Company Name: Synthes GmbH

Primary DI Number: 10886982077691
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: UPPER SIDE ARM FOR PELVIC C-CLAMP II

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47873	Pelvic C-clamp	A manual surgical instrument designed as an emergency stabilization device for unstable injuries and fractures of the pelvic ring; these conditions can be associated with massive blood loss and terminal shock. It is mechanically fixed to either side of the pelvis by means of thick nails permitting quick and efficient compression and stabilization of pelvic fractures and luxations providing time for haemorrhage and embolization control. It is typically designed as a C-shaped frame with a rail, twin adjustable arms, adjusting side screws, and nails made of high-grade stainless steel and/or synthetic material. It is compatible for use in computed tomography (CT). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JEC	COMPONENT, TRACTION, INVASIVE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071476	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f0594e0a-9189-45c6-987a-1a6719bff077
Public Version Date: October 17, 2023
Public Version Number: 5
DI Record Publish Date: September 14, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
HIBCC	H679033060020

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: Yes
DM DI Number: 07611819791398
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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