FDA.reportPublic FDA data

Guenter Bissinger Medizintechnik GmbH

Primary DI
04250418753142
Brand
Guenter Bissinger Medizintechnik GmbH
Company
Günter Bissinger Medizintechnik GmbH
Model
89817008
Catalog number
89817008
Device description
FROELICH Suction Tube 8 Fr., malleable, rotatable, WL 165 mm
Published
2025-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOLCATHETER AND TIP, SUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250418753142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250418753142042504187531424250418753142

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), typically to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497641914330info@bissinger.com

Regulatory Flags#

DUNS number
326515533
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250418748346Guenter Bissinger Medizintechnik GmbH82460326824603262026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbH82460349824603492026-07-21
04250418753395Guenter Bissinger Medizintechnik GmbH84919320849193202025-03-27
04250418753401Guenter Bissinger Medizintechnik GmbH84919321849193212025-03-27
04250418753418Guenter Bissinger Medizintechnik GmbH84921320849213202025-03-27
04250418753425Guenter Bissinger Medizintechnik GmbH84921321849213212025-03-27
04250418753432Guenter Bissinger Medizintechnik GmbH84923320849233202025-03-27
04250418753449Guenter Bissinger Medizintechnik GmbH84923321849233212025-03-27
04250418753296Guenter Bissinger Medizintechnik GmbH84923301849233012025-01-02
04250418753302Guenter Bissinger Medizintechnik GmbH84923310849233102025-01-02
04250418753319Guenter Bissinger Medizintechnik GmbH84923311849233112025-01-02
04250418753326Guenter Bissinger Medizintechnik GmbH84923330849233302025-01-02
04250418753333Guenter Bissinger Medizintechnik GmbH84923340849233402025-01-02
04250418753258Guenter Bissinger Medizintechnik GmbH84921311849213112024-12-18
04250418753265Guenter Bissinger Medizintechnik GmbH84921330849213302024-12-18
04250418753272Guenter Bissinger Medizintechnik GmbH84921340849213402024-12-18
04250418753289Guenter Bissinger Medizintechnik GmbH84923300849233002024-12-18
04250418753166Guenter Bissinger Medizintechnik GmbH84919300849193002024-12-17
04250418753173Guenter Bissinger Medizintechnik GmbH84919301849193012024-12-17
04250418753180Guenter Bissinger Medizintechnik GmbH84919310849193102024-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD911424030Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911424050Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911424060Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114241000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114251000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143009NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114301120Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143012NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311010Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311060Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311080Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911437070Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143709NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114511000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911451123NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114511310Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91145114510Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114521010Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114521020Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114521030Surgical DirectSurgical Direct, Inc.JOL2026-07-23
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00846159040692SCANLAN Minimally-Invasive InstrumentationSCANLAN INTERNATIONAL INCJOL2026-07-17
00846159040708SCANLAN®SCANLAN INTERNATIONAL INCJOL2026-07-17
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