FDA.reportPublic FDA data

NA

Primary DI
04250480112564
Brand
NA
Company
SCHÖLLY FIBEROPTIC GmbH
Model
05-0094l-nir
Device description
NIR FI Light Guide, 4.8 x 3000 mm
Published
2025-01-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EQHSource, Carrier, Fiberoptic Light

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQHSource, Carrier, Fiberoptic LightEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250480112564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250480112564042504801125644250480112564

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic light cable, reusableA flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length3000Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity5 Degrees Celsius95 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9999999999info@schoelly-usa.com

Regulatory Flags#

DUNS number
316276682
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250480101728NALG-7000X2024-12-03
04250480112809NA05.0085l.ht2024-01-08
04250480112816NA05.0087l2024-01-08
04250480112823NA05.0088l.ht2024-01-08
04250480112830NA05.0090l2024-01-08
04250480112847NA05.0090l.ht2024-01-08
04250480109038NA05-0094l-nir2023-10-30
04250480100202NA05.0084l2019-02-13
04250480100219NA05.0085l2019-02-13
04250480100226NA05.0086l2019-02-13
04250480100233NA05.0087l2019-02-13
04250480100240NA05.0088l2019-02-13
04250480100257NA05.0090l2019-02-13
04250480100264NA05.0090l.ht2019-02-13
04250480106914NA05.0085l.ht2019-02-13
04250480106976NA05.0088l.ht2019-02-13
04250480104200NA95-39092025-06-11
04250480104262N/A05-0762nir2025-06-11
04250480103906NA41-0005a2025-04-09
04250480112519NA11-0131nir2025-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506090868ELMED INCORPORATEDELMED INCORPORATEDEQH2026-05-18
00190776417680MillenniumAvalign Technologies, Inc.EQH2026-03-04
00198506088841ELMED INCORPORATEDELMED INCORPORATEDEQH2026-02-23
00190776415716MillenniumAvalign Technologies, Inc.EQH2026-02-04
00198506088056ELMED INCORPORATEDELMED INCORPORATEDEQH2026-01-22
00198506087059ELMED INCORPORATEDELMED INCORPORATEDEQH2025-12-03
00198506086786ELMED INCORPORATEDELMED INCORPORATEDEQH2025-11-25
00198506086854ELMED INCORPORATEDELMED INCORPORATEDEQH2025-11-25
00198506086908ELMED INCORPORATEDELMED INCORPORATEDEQH2025-11-25
00198506086250ELMED INCORPORATEDELMED INCORPORATEDEQH2025-10-20
00190776413347MillenniumAvalign Technologies, Inc.EQH2025-10-09
04250676736000Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736024Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736031Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736055Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
00198506085079ELMED INCORPORATEDELMED INCORPORATEDEQH2025-09-05
00840183530679BR Surgical, LLCBR Surgical, LLCEQH2025-09-05
00190776408534MillenniumAvalign Technologies, Inc.EQH2025-08-19
00194613020132MSI Precision Specialty InstrumentsMed Saver, Inc.EQH2025-08-01
00194613123154MSI Precision Specialty InstrumentsMed Saver, Inc.EQH2025-08-01
00190776406769MillenniumAvalign Technologies, Inc.EQH2025-07-24
00190776406431MillenniumAvalign Technologies, Inc.EQH2025-07-21
00190776377137MillenniumAvalign Technologies, Inc.EQH2025-07-18
00190776406172MillenniumAvalign Technologies, Inc.EQH2025-07-18
00198506084089ELMED INCORPORATEDELMED INCORPORATEDEQH2025-07-17
00190776402815MillenniumAvalign Technologies, Inc.EQH2025-06-30
00198506083716ELMED INCORPORATEDELMED INCORPORATEDEQH2025-06-23
00190776401474MillenniumAvalign Technologies, Inc.EQH2025-06-10
00190776400019MillenniumAvalign Technologies, Inc.EQH2025-06-03
00198506083020ELMED INCORPORATEDELMED INCORPORATEDEQH2025-05-28