Busse Hospital Disposables

Primary DI
20849233013036
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
384
Catalog number
384
Device description
Umbilical Cord Clamp
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HFWClamp, Umbilical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010835000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010835000POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385Busse Hospital Disposables, Inc.2001-04-30HFW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849233013039PackageGS12In Commercial Distribution
20849233013036PackageGS164In Commercial Distribution
00849233013032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923301303910849233013039
2084923301303620849233013036
00849233013032008492330130328492330130320849233013032

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

Contacts#

Phone, Email table
PhoneEmail
1 (631) 435-4711mail@busseinc.com

Regulatory Flags#

DUNS number
002418234
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849233010277Busse Hospital Disposables949794972020-04-02
00849233010376Busse Hospital Disposables954595452020-04-03
00849233004481Busse Hospital Disposables249124912016-09-20
00849233017276Busse Hospital Disposables40432026-05-28
00849233015906Busse Hospital DisposablesB84822026-05-27
00849233016538Busse Hospital Disposables40122026-05-21
00849233016958Busse Hospital Disposables40172026-05-21
00849233003750Busse Hospital DisposablesB1326B13262020-06-25
00849233003767Busse Hospital DisposablesB1328B13282020-06-25
00849233005129Busse Hospital DisposablesB1435B14352020-10-20
00849233014350Busse Hospital Disposables29112026-04-27
00849233014817Busse Hospital Disposables29602026-04-27
00849233000193Busse Hospital Disposables6007R16007R12016-09-14
00849233006256Busse Hospital Disposables173917392021-08-18
00849233011304Busse Hospital Disposables289328932016-09-13
00849233011359Busse Hospital Disposables327232722016-09-13
00849233011724Busse Hospital Disposables562156212016-09-13
00849233015036Busse Hospital Disposables356935692016-09-13
00849233015869Busse Hospital Disposables679067902016-09-13
00849233017733Busse Hospital Disposables679167912016-09-13

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
10851121007006AlphaALPHA INDUSTRIES INCHFW2016-09-16
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
10849233018102Busse Hospital DisposablesROBERT BUSSE & CO., INC.HFW2016-09-01