AccessGUDID - DEVICE: SURGICOUNT (07613327513301)

GUDID

Device Identifier (DI) Information

Brand Name: SURGICOUNT
Version or Model: 0694002004
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0694-002-004
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327513301
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: + CRADLE POLE MOUNT

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?
61906	Electronic surgical sponge-counter	A hand-held battery-powered computerized device intended to be used in the operating room (OR) by professional staff to electronically maintain the count of surgical sponges/swabbing materials during a surgical procedure to prevent swabs from being inadvertently left in a patient. It typically has controls/keyboard, display and built-in bar-code reader, whereby packs of surgical sponges entering the surgical field are intended to be scanned in and counted out. It may include device for battery recharging or connection to a personal computer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LWH	Counter, sponge, surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Handling Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 27ae8e31-5b8b-45d4-aae1-a9ae8386c94a
Public Version Date: June 17, 2021
Public Version Number: 1
DI Record Publish Date: June 09, 2021

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +0018002533210
Email: Inst.Stryker.cs@Stryker.com

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