FDA.report

Scanlan® SURG-I-PAW® Instrument Covers

Primary DI
00846159028942
Brand
Scanlan® SURG-I-PAW® Instrument Covers
Company
SCANLAN INTERNATIONAL INC
Model
1001-72B
Catalog number
1001-72B
Device description
Scanlan® SURG-I-PAW® Instrument Covers - Red, 1/10" x 5"/ 3 mm x13 cm, BNS (20 per /pkg)
Published
2018-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GDJClamp, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00846159028942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159028942008461590289428461590289420846159028942

GMDN Terms

TermDefinition
Vascular bootiesA sterile cover, used in pairs, fitted onto the distal working end (the jaws) of artery forceps, vascular clamps, or similar surgical instruments, to provide improved grip for delicate sutures. It is typically tube-like with a closed, rounded tip and composed of radiopaque silicone materials. It is available in various sizes and may be straight or curved. The pair of devices may also be known as "jaw covers" (shods). This is a single-use device.

Sterilization Methods

Method
Radiation Sterilization

Contacts

PhoneEmail
651-298-0997vanderpoelw@scanlangroup.com

Regulatory Flags

DUNS number
023055619
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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