FDA.report

SURGISTAR

Primary DI
00878799005540
Brand
SURGISTAR
Company
SURGISTAR, INC.
Model
330001
Published
2016-08-02
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
GDZHandle, Scalpel

Product Code Classifications

CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00878799005540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00878799005540008787990055408787990055400878799005540

GMDN Terms

TermDefinition
Corneal resection holder, single-useA device designed to hold donated corneal tissue so that it can be resected in preparation for transplantation. The device may be in the form of a pedestal, with retention and locking rings, upon which the donated cornea is placed and inflated with air, or some other material, to simulate the pressure of the anterior chamber of the eye for the procedure. This method allows resection from the epithelial side of the cornea. The device may also include tubing and clips, and inflation is typically achieved manually with a syringe. 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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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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B382SD914010350Surgical DirectSurgical Direct, Inc.GDZ2026-02-25
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