FDA.reportPublic FDA data

SCHWERT

Primary DI
E89625579220
Brand
SCHWERT
Company
A. Schweickhardt GmbH & Co. KG
Model
25579-22
Catalog number
25579-22
Device description
Anuscopes 22x65mm HIRSCHMANN
Published
2023-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAFSpatula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E89625579220PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Anoscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a light source and can be viewed by the user through relayed lens optics or direct vision. This device is commonly used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49746498910700contact@schwert.com

Regulatory Flags#

DUNS number
341195628
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E8961411020SCHWERT1411-021411-022026-05-21
E8961411050SCHWERT1411-051411-052026-05-21
E896143650SCHWERT1436-51436-52026-04-16
E8961125400B0SCHWERT1125-400B1125-400B2026-03-18
E89628870SCHWERT288728872025-12-16
E8961490500SCHWERT1490-501490-502025-11-27
E8961145610SCHWERT11456-111456-12025-10-15
E89616970207E0SCHWERT1697-02-07E1697-02-07E2025-10-14
E89616970307E0SCHWERT1697-03-07E1697-03-07E2025-10-14
E89616970TI07E0SCHWERT1697-0TI-07E1697-0TI-07E2025-10-14
E8961705207E0SCHWERT1705-2-07E1705-2-07E2025-10-14
E8961705307E0SCHWERT1705-3-07E1705-3-07E2025-10-14
E8961705607E0SCHWERT1705-6-07E1705-6-07E2025-10-14
E89617057507E0SCHWERT1705-75-07E1705-75-07E2025-10-14
E896193950SCHWERT19395193952025-10-14
E89617059007E0SCHWERT1705-90-07E1705-90-07E2025-09-04
E89617059101E0SCHWERT1705-91-01E1705-91-01E2025-09-04
E89617059206E0SCHWERT1705-92-06E1705-92-06E2025-09-04
E89617059303E0SCHWERT1705-93-03E1705-93-03E2025-09-04
E896169701TI07E0SCHWERT1697-01TI-07E1697-01TI-07E2025-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08961104622555Spatula 8.0 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
08961104622562Spatula 10 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
00840343727352GEN2SURGIX MEDICAL LLCGAF2026-04-16
10889950147624Hu-FriedyHU-FRIEDY MFG. CO., LLCGAF2026-02-24
00840018668164Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-02-10
00840018662810Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00840018662827Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00810158218420PRINCETONPrinceton Medical Group, Inc.GAF2026-01-07
B382SD9150391000Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391050Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391060Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150471120Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD915095250Surgical DirectSurgical Direct, Inc.GAF2025-12-29
08800075627766OSUNG MNDOSUNG MND Co., Ltd.GAF2025-11-03
00810158217652PRINCETONPrinceton Medical Group, Inc.GAF2025-10-17
00810158217669PRINCETONPrinceton Medical Group, Inc.GAF2025-10-17
B382SD571002EM0Surgical DirectSurgical Direct, Inc.GAF2025-10-06
B382SD572425E0Surgical DirectSurgical Direct, Inc.GAF2025-10-06
00810158217263PRINCETONPrinceton Medical Group, Inc.GAF2025-09-25
04250676741431SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
04250676741448SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
04250676741455SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
B382SD915095450Surgical DirectSurgical Direct, Inc.GAF2025-08-11
00840343725792GEN2SURGIX MEDICAL LLCGAF2025-06-16
00840343725808GEN2SURGIX MEDICAL LLCGAF2025-06-16
00840343725815GEN2SURGIX MEDICAL LLCGAF2025-06-16
10649111448614Sklar InstrumentsSKLAR CORPORATIONGAF2025-05-29
50649111448612Sklar InstrumentsSKLAR CORPORATIONGAF2025-05-29
B382SD915039100Surgical DirectSurgical Direct, Inc.GAF2025-05-19