FDA.report

SURGISTAR

Primary DI
00878799008060
Brand
SURGISTAR
Company
SURGISTAR, INC.
Model
496106
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
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HNCSpecula, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNCSpecula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00878799008060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00878799008060008787990080608787990080600878799008060

GMDN Terms

TermDefinition
Eyelid speculum, reusableA self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours and is usually made of stainless steel. This is a reusable 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
false
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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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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