AccessGUDID - DEVICE: Millennium (00190776154042)

GUDID

Device Identifier (DI) Information

Brand Name: Millennium
Version or Model: 72-5251530B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Avalign Technologies, Inc.

Primary DI Number: 00190776154042
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 792528510 *Terms of Use

Device Description: GASTRIC BAND MANIPULATOR, 10MM, 36CM, ROTATABLE, RING HANDLE, WITH RATCHET

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?
32617	Laparoscope system, reusable	An assembly of laparoscopes and their accessories used for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs (laparoscopy). The insertion is typically through an incision(s) made in the abdominal wall (routinely just below the umbilicus or in the near vicinity). This system is mostly used for gynaecological procedures involving the evaluation/treatment of abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, or for female sterilization. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181173	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: 5e2b0727-ea53-4f08-bf91-b01568819aa6
Public Version Date: July 06, 2023
Public Version Number: 2
DI Record Publish Date: July 07, 2020

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: +1(877)289-1096
Email: product.questions@avalign.com

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