AccessGUDID - DEVICE: NA (20886982198621)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 392.177
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 392177
Company Name: Synthes GmbH

Primary DI Number: 20886982198621
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: PROTECTIVE CAPS FOR 1.0MM/1.25MM KIRSCHNER WIRES

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:	Yes
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?
35647	External orthopaedic fixation system, reusable	An assembly of devices designed to stabilize fractured bones, other than those in the vertebral column, to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, cams, bushings, collars, bolts and nuts; it may also include some instrumentation (e.g., screw drivers, wrenches, drills). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the wrist, elbow, knee, hip and ankle, joint fusions, and limb lengthening. This is a reusable device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HRS	PLATE, FIXATION, BONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K001941	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: ca8c4d93-5870-477a-b917-ae15911af224
Public Version Date: May 02, 2022
Public Version Number: 4
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	H6793921770

Unit of Use DI

[?]

Unit of Use DI Number: 80886982198623 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
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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