FDA.reportPublic FDA data

Busse Hospital Disposables

Primary DI
00849233002425
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
781
Device description
Suture-Glide (TM) Webster Needle Holder with large Loops
Published
2023-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849233002422PackageGS125In Commercial Distribution
00849233002425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923300242210849233002422
00849233002425008492330024258492330024250849233002425

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, single-useA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
002418234
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849233017511Busse Hospital DisposablesB20862026-07-21
00849233017528Busse Hospital DisposablesB20282026-07-21
00849233017344Busse Hospital DisposablesB17122026-06-25
00849233017375Busse Hospital DisposablesB17132026-06-25
00849233014329Busse Hospital Disposables30342026-03-25
00849233017948Busse Hospital Disposables30922026-06-23
00849233013797Busse Hospital Disposables9792026-06-09
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776422004MillenniumAvalign Technologies, Inc.FSM2026-07-23
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18059015378375Flexible Reamers SystemORTHOFIX SRLFSM2026-07-23
18059015378382Flexible Reamers SystemORTHOFIX SRLFSM2026-07-23
00841731153258ARTEMIS FUZEVILEX LLCFSM2026-07-22
00841731153265ARTEMIS TAKEDOWNVILEX LLCFSM2026-07-22
B803PW12A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW14G0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW18A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW20ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW22A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW26A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW30A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW32A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW40A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW6G0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
00840606195737ViaductSPINAL ELEMENTS, INC.FSM2026-07-20
00843059127478LattusTEDAN SURGICAL INNOVATIONS, L.L.C.FSM2026-07-20
07613327602241NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602296NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602302NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602326NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602418NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663518NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663525NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663532NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663549NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663556NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663563NAStryker Leibinger GmbH & Co. KGFSM2026-07-17