AccessGUDID - DEVICE: Momentum MIS (00810076332840)

GUDID

Device Identifier (DI) Information

Brand Name: Momentum MIS
Version or Model: UU092-70-0100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ulrich Medical Usa, Inc.

Primary DI Number: 00810076332840
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 624083866 *Terms of Use

Device Description: Counter-torque, external

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?
47554	Orthopaedic counter-torque/rod-pushing instrument	A hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NKB	Thoracolumbosacral Pedicle Screw System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223274	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: 3c080b80-c48d-4a57-9a50-271ec1430d35
Public Version Date: June 20, 2024
Public Version Number: 2
DI Record Publish Date: March 13, 2024

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
No Secondary DIs found

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: 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: 636-519-0268
Email: info@ulrichmedicalusa.com

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