FDA.reportPublic FDA data

Alpha

Primary DI
10851121007006
Brand
Alpha
Company
ALPHA INDUSTRIES INC
Model
Product 556
Published
2016-09-16
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
HFWClamp, Umbilical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFWClamp, UmbilicalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851121007006PrimaryGS10
00851121007009Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085112100700610851121007006
00851121007009008511210070098511210070090851121007009

GMDN Terms#

Term, Definition table
TermDefinition
Umbilical cord clamp, single-useA sterile, hand-held manual surgical instrument designed to temporarily compress the umbilical cord immediately after birth. It is used before cutting or ligating (e.g., with a clip) the cord, and is intended to enable aseptic haemostasis. It is typically made of plastic material and may incorporate features such as serrations on the contact area and/or a security lock. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
073197881
Device count
1000
Lot or batch
true
Sterilization required before use
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885632431364MedichoiceOWENS & MINOR DISTRIBUTION, INC.HFW2024-10-30
30885632431368MedichoiceOWENS & MINOR DISTRIBUTION, INC.HFW2024-10-30
00840183513856BR Surgical, LLCBR Surgical, LLCHFW2024-07-22
00840113231508Double-Grip Umbilical Cord ClampASPEN SURGICAL PRODUCTS, INC.HFW2023-02-27
10840113231512Double-Grip Umbilical Cord ClampASPEN SURGICAL PRODUCTS, INC.HFW2023-02-27
10840113231529Double-Grip Umbilical Cord ClampASPEN SURGICAL PRODUCTS, INC.HFW2023-02-27
10809160306086HalyardAVID MEDICAL, INC.HFW2020-12-10
20809160306083HalyardAVID MEDICAL, INC.HFW2020-12-10
10080196493401MEDLINEMEDLINE INDUSTRIES, INC.HFW2020-05-18
40080196493402MEDLINEMEDLINE INDUSTRIES, INC.HFW2020-05-18
10767056094212MABIS DMID-M-S HOLDINGS, INC.HFW2020-02-17
10809160173503AVID TruCustomAVID MEDICAL, INC.HFW2017-12-15
10809160153789AVID TruCustomAVID MEDICAL, INC.HFW2017-07-07
00653160021387CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHFW2017-03-03
50653160021382CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHFW2017-03-03
00653160010619CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHFW2016-11-30
50653160010614CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHFW2016-11-30
04038653155040AESCULAPAesculap AGHFW2016-09-23
10767056094113MABIS DMID-M-S HOLDINGS, INC.HFW2016-09-23
10767056094236MABIS DMID-M-S HOLDINGS, INC.HFW2016-09-23
10767056113845MABIS DMID-M-S HOLDINGS, INC.HFW2016-09-23
10767056113852MABIS DMID-M-S HOLDINGS, INC.HFW2016-09-23
10767506094212MABIS DMID-M-S HOLDINGS, INC.HFW2016-09-23
10809160030141AVID TruCustomAVID MEDICAL, INC.HFW2016-09-09
00849233013032Busse Hospital DisposablesROBERT BUSSE & CO., INC.HFW2016-09-01
00849233018105Busse Hospital DisposablesROBERT BUSSE & CO., INC.HFW2016-09-01
20849233013036Busse Hospital DisposablesROBERT BUSSE & CO., INC.HFW2016-09-01
10849233018102Busse Hospital DisposablesROBERT BUSSE & CO., INC.HFW2016-09-01