FDA.report

SURGISTAR

Primary DI
10878799000238
Brand
SURGISTAR
Company
SURGISTAR, INC.
Model
1800
Published
2016-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GDXScalpel, One-Piece

Product Code Classifications

CodeDeviceSpecialtyClass
GDXScalpel, One-PieceGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10878799000238PackageGS14In Commercial Distribution
00878799000231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1087879900023810878799000238
00878799000231008787990002318787990002310878799000231

GMDN Terms

TermDefinition
Scalpel blade, single-useA sterile interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
17605982480CUSTOMERSERVICE@SURGISTAR.COM

Regulatory Flags

DUNS number
808865125
Device count
1
DM exempt
false
Premarket exempt
false
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
false

Other Devices From This Company

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10878799003079Surgistar9400122021-02-24
10878799003147Surgistar1920012021-02-24
00878799003294Surgistar3318012021-02-24
10878799003314Surgistar7889152021-02-24
10878799003321Surgistar7891152021-02-24
10878799003352Surgistar8818492021-02-24
10878799003369Surgistar8822492021-02-24
10878799003376Surgistar8824492021-02-24
10878799003383Surgistar8840222021-02-24
10878799003390Surgistar8822392021-02-24
00878799003409Surgistar8827392021-02-24
10878799003413Surgistar9603502021-02-24
10878799003420Surgistar9603002021-02-24
10878799003444Surgistar8855852021-02-24
10878799003451Surgistar9655852021-02-24
10878799004892Surgistar9400112021-02-24
10878799004908Surgistar1250082021-02-24
10878799004915Surgistar1251792021-02-24
10878799004939Surgistar126-MINDE-1.3A2021-02-24

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