AccessGUDID - DEVICE: NA (00681490142656)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 6177
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00681490142656
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: ACCESS 6177 10BX STERILE RF HEAD COVER

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?
58968	Instrument management bag	A flexible plastic container intended to hold/collect instruments, cables, or other equipment during a surgical procedure or other clinical intervention, typically being attached to a drape or other support close to or inside the sterile field of operation/intervention. It may have a variety of designs, e.g., number of pouches, adhesive/non-adhesive, overall shape and size. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OSR	Pacemaker/icd/crt non-implanted components
KRG	Programmer, pacemaker

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P890003	065

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -29 and 135 Degrees Fahrenheit
Storage Environment Humidity: less than 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 120.0 Inch

Device Record Status

Public Device Record Key: 6c308c9c-0ade-4569-a008-67de8c1d995d
Public Version Date: July 31, 2023
Public Version Number: 4
DI Record Publish Date: September 23, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10681490142653	10	00681490142656		In Commercial Distribution	PK

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(800)633-8766
Email: Corporate.UDI@medtronic.com

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