FDA.reportPublic FDA data

Gimmi

Primary DI
04049047316848
Brand
Gimmi
Company
Gimmi GmbH
Model
PU.1630.08
Catalog number
PU.1630.08
Device description
SIMS RECTAL SPECULAFIG. 2LENGTH 240 MM
Published
2025-05-20
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
FFQSpeculum, Rectal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFQSpeculum, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049047316848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049047316848040490473168484049047316848

GMDN Terms#

Term, Definition table
TermDefinition
Rectal speculumA hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. It is comprised of two arms joined at a pivot point and is available in various sizes, shapes, and contours; it is usually made of stainless steel. The instrument is used for examination or for the insertion of other instrumentation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497461965900contact@gimmi.de

Regulatory Flags#

DUNS number
316152610
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
04049047003137GimmiAA.1502.192026-05-18
04049047787815GimmiLIG.4148.30LIG.4148.302025-03-20
04049047788119GimmiLIG.4148.98LIG.4148.982025-03-20
04049047657545NAE.8230.48 LED2023-05-03
04049047657569GimmiE.8300.48 LEDE.8300.48 LED2023-02-14
04049047042563GimmiE.8230.45XE.8230.45X2017-05-05
04049047043164GimmiE.8300.35E.8300.352017-05-05
04049047043171GimmiE.8300.48E.8300.482017-05-05
04049047043430GimmiE.8997.00E.8997.002017-05-05
04049047043447GimmiE.8998.01E.8998.012017-05-05
04049047126379GimmiE.8230.41E.8230.412017-05-05
04049047127086GimmiE.8000.00E.8000.002017-05-05
04049047127246GimmiE.8230.45X SETE.8230.45X SET2017-05-05
04049047203322GimmiE.8300.45XE.8300.45X2017-05-05
04049047631675GimmiE.8998.02E.8998.022017-05-05
04049047643289GimmiE.8300.48X SETE.8300.48X SET2017-05-05
04049047064725GimmiM.1701.08M.1701.082025-05-20
04049047064848GimmiM.1721.12M.1721.122017-05-05
04049047788553GimmiCAM.1113.002026-03-04
04049047788577GimmiCAM.1113.902026-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055445961107SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961114SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961121SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961138SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961145SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961152SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961169SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961176SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961183SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961190SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961206SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961213SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961220SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961237SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961244SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961251SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961282SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961299SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961305SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961312SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961329SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961336SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961343SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961350SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961367SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961374SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961381SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961398SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961404SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961411SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12