FDA.reportPublic FDA data

SURGYCO

Primary DI
20850049784195
Brand
SURGYCO
Company
Surgyco LLC
Model
GS000425
Device description
Non-Woven Sponge, 4" x 4" 4Ply, 30Grams
Published
2023-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850049784195PackageGS12000In Commercial Distribution
10850049784198PrimaryGS10
00850049784191Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085004978419520850049784195
1085004978419810850049784198
00850049784191008500497841918500497841910850049784191

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118768538
Device count
200
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
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850074089060Surgyco010-VPSB21G22025-12-23
10850074089077Surgyco010-VPSB23G22025-12-23
10850074089084Surgyco010-VPSB25G22025-12-23
10850074089091Surgyco010-VPB23G22025-12-23
10850074089107Surgyco010-VPN01102025-12-23
10850074089114Surgyco010-VPN01202025-12-23
20850074089067Surgyco010-VPSB21G22025-12-23
20850074089074Surgyco010-VPSB23G22025-12-23
20850074089081Surgyco010-VPSB25G22025-12-23
20850074089098Surgyco010-VPB23G22025-12-23
20850074089104Surgyco010-VPN01102025-12-23
20850074089111Surgyco010-VPN01202025-12-23
10850053289672SurgycoSEN102302025-12-11
20850053289679SurgycoSEN102302025-12-11
10850074089053ClinicoLab010-16622025-09-10
10850053289870SURGYCOSSNG00102025-07-11
10850053289887SURGYCOSSNG00152025-07-11
10850053289894SURGYCOSSNG00202025-07-11
10850074089015JDL Sensitive010-12502025-07-11
10850074089022JDL Sensitive010-12602025-07-11

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