AccessGUDID - DEVICE: NA (10887587025902)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 05.505.003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 05505003
Company Name: Synthes GmbH

Primary DI Number: 10887587025902
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: INSTRUMENT FOR REMOVAL OF INSERTS FOR 90° SCREWDRIVER

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?
60447	Surgical power tool maintenance adaptor	A device intended to connect a surgical power tool (e.g., pneumatically or electrically driven motors, turbines, or attachments) to a maintenance device (i.e., maintenance unit or lubricant container) during maintenance/lubrication of the surgical power tool. It is typically a metal attachment designed to connect a specific type of tool and maintenance device together.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWE	INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
DZI	DRILL, BONE, POWERED
DZJ	DRIVER, WIRE, AND BONE DRILL, MANUAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082649	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: ef230a1f-f651-474b-bf6f-f8089363f9cd
Public Version Date: August 16, 2022
Public Version Number: 4
DI Record Publish Date: June 30, 2016

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	H980055050030

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: 07611819197480
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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