AccessGUDID - DEVICE: NA (10886982129130)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 05.001.092
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 05001092
Company Name: Synthes GmbH

Primary DI Number: 10886982129130
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: ADAPTOR FOR MAINTENANCE SPRAY FOR AIR PEN DRIVE

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
HBB	MOTOR, DRILL, PNEUMATIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093361	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 9adf0217-731e-496a-9789-49e657869eb5
Public Version Date: April 18, 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	H679050010920

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: 07611819868113
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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