AccessGUDID - DEVICE: SafeSheath® II (30891492002303)

GUDID

Device Identifier (DI) Information

Brand Name: SafeSheath® II
Version or Model: SS12
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SS12
Company Name: Oscor Inc.

Primary DI Number: 30891492002303
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 101835833 *Terms of Use

Device Description: Hemostatic Tear-away Introducer System with Infusion Side Port, 12F

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?
58865	Vascular catheter introduction set, nonimplantable	A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYB	INTRODUCER, CATHETER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122084	000

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 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Sheath Length 13 cm
Device Size Text, specify: Dilator Length 19.5 cm
Device Size Text, specify: Guidewire Length 50 cm
Needle Gauge: 18 Gauge

Device Record Status

Public Device Record Key: 8ad3b9cd-6d6e-4b2e-9644-0798507f3970
Public Version Date: February 04, 2026
Public Version Number: 6
DI Record Publish Date: November 27, 2017

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: 00891492002302 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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(727)937-2511
Email: sales@oscor.com

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