FDA.reportPublic FDA data

count-me-out

Primary DI
00850045406448
Brand
count-me-out
Company
General Hospital Supply Corp
Model
CMO-15
Catalog number
CMO-15
Device description
Count Sheet Holder for Wrapped Sets
Published
2022-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00850045406448PrimaryGS10
10850045406445Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045406448008500454064488500454064480850045406448
1085004540644510850045406445

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, single-useA device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. This is a single-use device.

Regulatory Flags#

DUNS number
055852834
Device count
1000
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850045406615clamp-itCOO-1COO-12026-10-01
00850045406035rack-n-stack011701172022-09-14
00850045406011rack-n-stack010801082022-09-14
00850045406004rack-n-stack010201022022-09-12
00850045406592bio-trayBT-1121BT-11212024-08-15
10850045406599bio-trayBT-1121BT-11212024-08-15
00850045406585triple-liner602260222023-08-17
10850045406582triple-liner602260222023-08-17
00850045406028rack-n-stack011201122022-09-14
00850045406257fold-n-hold089508952022-09-20
00850045406264fold-n-hold081208122022-09-20
00850045406271fold-n-hold050505052022-09-20
00850045406288fold-n-hold041704172022-09-20
00850045406295fold-n-hold101010102022-09-20
00850045406387plasma-tazzS0607S06072022-09-20
00850045406394plasma-tazzS0810S08102022-09-20
00850045406400plasma-tazzS3511S35112022-09-20
00850045406417plasma-tazzS3517S35172022-09-20
00850045406424count-me-outCMO-10CMO-102022-09-20
00850045406431count-me-outCMO-11CMO-112022-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810161901791EARP, IMPLANT LID 22X50RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-15
M697X07300151Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.LRP2026-10-14
M697X07300261Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.LRP2026-10-14
M697X07300271Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.LRP2026-10-14
M697X07300291Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.LRP2026-10-14
10198956603554CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-13
10198956612822CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-13
10198956618688CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-13
10198956578487CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956580961CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956591578CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956595576CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956604506CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956604551CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956604568CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956605732CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956605848CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956605855CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956606807CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956607668CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608351CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608900CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608924CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608931CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608948CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956608955CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956609341CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
10198956610651CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-12
G141588225750Carnegie Surgical LLCCarnegie Surgical LLCLRP2026-10-07
00810017915293Saber-XA, Trial CaddyELEVATION SPINE, INC.LRP2026-10-06