FDA.reportPublic FDA data

Archbold C-Section

Primary DI
00817395022292
Brand
Archbold C-Section
Company
PACKROOM LLC
Model
AM160
Device description
Archbold C-Section
Published
2021-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817395022292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817395022292008173950222928173950222920817395022292

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
015179820
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817395024425Kit, Ped Intub Gray 3-5kg NGHSKT7700AINA2026-04-27
00817395024418Pack, CABG KennestoneWK221A2026-03-18
00817395024401NEGA Lithotomy RFID PackNG115RFA2026-02-20
00817395024364Pack, Angio HamiltonHM105A2025-09-03
00817395024357Kennestone Upper Extremity PackWK420B2025-09-02
00817395024203Pack, Basic NEGA *RFIDNG235RFD2025-04-09
00817395024067Kit, Kennestone PermacathKT410.0012024-06-25
00817395024074Kit, Sub Extremity NEGAKT420.0022024-06-25
00817395024081Kit, Ped Intub Blue 19-23kg NGHSKT7700BIN.0072024-06-25
00817395024098Kit, Ped Nurse Blue 19-23kg NGHSKT7700BIV.0032024-06-25
00817395024104Kit, Ped Intub Green 30-36kg NGHSKT7700GIN.0052024-06-25
00817395024111Kit, Ped Nurse Green 30-36kg NGHSKT7700GIV.0022024-06-25
00817395024128Kit, Ped Intub Orange 24-29kg NGHSKT7700OIN.0042024-06-25
00817395024135Kit, Ped Nurse Orange 24-29kg NGHSKT7700OIV.0012024-06-25
00817395024142Kit, Ped Intub Purple 10-11kg NGHSKT7700PIN.0052024-06-25
00817395024159Kit, Ped Nurse Purple 10-11kg NGHSKT7700PIV.0012024-06-25
00817395024166Kit, Ped Intub Pink/Red 6-9kg NGHSKT7700RIN.0072024-06-25
00817395024173Kit, Ped Nurse White 15-18kg NGHSKT7700WIV.0022024-06-25
00817395024180Kit, Ped Intub Yellow 12-14kg NGHSKT7700YIN.0052024-06-25
00817395024197Kit, Ped Nurse Yellow 12-14kg NGHSKT7700YIV.0022024-06-25