FDA.report

SURGISTAR

Primary DI
10878799001044
Brand
SURGISTAR
Company
SURGISTAR, INC.
Model
882969
Published
2016-09-16
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

Product Codes

CodeName
EMFKnife, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10878799001044PackageGS16In Commercial Distribution
00878799001047PrimaryGS10

GMDN Terms

TermDefinition
Scalpel, single-useA hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. 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
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
false

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10878799003420Surgistar9603002021-02-24
10878799003444Surgistar8855852021-02-24
10878799003451Surgistar9655852021-02-24
10878799004892Surgistar9400112021-02-24
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10878799004915Surgistar1251792021-02-24
10878799004939Surgistar126-MINDE-1.3A2021-02-24

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00848530100179GuideBlade Sample KitSUNSET HEALTHCARE SOLUTIONS, INC.EMF2025-12-09
08681506801302SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2025-12-09
08681506801227SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2025-12-08
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08717903490310Humeca Watson knifeHumeca B.V.EMF2025-05-20
08717903490327Humeca Humby long knifeHumeca B.V.EMF2025-05-20
00190776397616MillenniumAvalign Technologies, Inc.EMF2025-05-16
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