FDA.reportPublic FDA data

Plasma-Cel Small Single Pouch

Primary DI
10843356101512
Brand
Plasma-Cel Small Single Pouch
Company
CYGNUS MEDICAL L.L.C.
Model
PC6250
Device description
Plasma-Cel Small Single Pouch 2-1/4 in. x 7-1/2 in. - 50 Small Single Pouches
Published
2020-09-24
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
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843356101512PackageGS18In Commercial Distribution
00843356101515PrimaryGS10
30843356101516Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084335610151210843356101512
00843356101515008433561015158433561015150843356101515
3084335610151630843356101516

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, single-use, non-sterileA non-sterile device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during a procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103169095
Device count
50
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843356102932CYGNUSLTS12122026-02-16
00843356102949CYGNUSLTS12162026-02-16
00843356102956CYGNUSLTS24242026-02-16
00843356102963CYGNUSASO3E1602026-01-15
00843356102888CYGNUSASO3E1902025-12-16
00843356102895CYGNUSASO6E1602025-12-16
00843356102857CYGNUSCCL5002025-07-11
00843356102864CYGNUSSTR5002025-07-11
00843356101812Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12GIC190R2024-12-31
00843356101829Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12GIC270R2024-12-31
10843356102694CYGNUSGTG-A-20002024-12-11
90843356102744CYGNUSEC03082024-11-20
90843356102751CYGNUSEC0308-SI2024-11-20
90843356102768CYGNUSEC06122024-11-20
90843356102775CYGNUSEC0612-SI2024-11-20
90843356102782CYGNUSEC07132024-11-20
90843356102799CYGNUSEC0713-SI2024-11-20
00843356102840CYGNUSHLD250R2024-11-20
90843356102805CYGNUSTBLT-RL2024-09-11
00843356102819CYGNUSSCC152024-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956470613CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
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10198956488533CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956491236CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956492592CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956492998CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956494824CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
04046826447953Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
04046826495923Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
04046826495978Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
50198956435382CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-24
50198956248968CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956284027CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956293043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956304954CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956305630CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956308433CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956313703CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956322590CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956325607CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956331677CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956332292CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956348255CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956356526CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23