FDA.reportPublic FDA data

Satin™

Primary DI
00634782575670
Brand
Satin™
Company
AMERICAN DIAGNOSTIC CORP
Model
4080-0D-20
Catalog number
4080-0D-20
Device description
Miller Blade, Disposable,#00, 20/pkg
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634782575670PackageGS16In Commercial Distribution
00634782074395PrimaryGS10
00634782074388Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782575670006347825756706347825756700634782575670
00634782074395006347820743956347820743950634782074395
00634782074388006347820743886347820743880634782074388

GMDN Terms#

Term, Definition table
TermDefinition
Rigid intubation laryngoscope, reusableA hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types can be magnetic resonance imaging (MRI) compatible. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags#

DUNS number
108999095
Device count
20
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634782902636Adcuff™ 920-011N920-011N2026-02-23
00634782101695ADC®381N381N2026-02-20
00634782903213ADC®380N380N2026-02-20
00634782903190Advantage™611561152025-11-24
00634782903152Advantage™611261122025-09-19
00634782903169Advantage™612161212025-09-19
00634782903176Advantage™6121SA6121SA2025-09-19
00634782903183Advantage™6121X6121X2025-09-19
00634782903091Adtemp™ 424N-40424N-402025-02-05
00634782603106Adtemp™ 424N-200424N-2002025-02-05
00634782903039Adtemp™ 424N424N2025-01-29
00634782600402Adscope®608LPST608LPST2023-01-11
00634782600600Adscope®600IMCA600IMCA2023-01-10
00634782600617Adscope®600IST600IST2023-01-10
00634782600624Adscope®601IMCA601IMCA2023-01-10
00634782600631Adscope®601IST601IST2023-01-10
00634782600648Adscope®601RGBK601RGBK2023-01-10
00634782600655Adscope®608RGBK608RGBK2023-01-10
00634782600662Adscope®608RGW608RGW2023-01-10
00634782600679Adscope®606RGBK606RGBK2023-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089633ELMED INCORPORATEDELMED INCORPORATEDCCW2026-03-17
06974525071507Video LaryngoscopeShenzhen Zhixin Biomedical Technology Co., Ltd.CCW2026-02-04
00198506088063ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-22
00198506087868ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
00198506087875ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
00198506087882ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
00198506087905ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
05707480164264Ambu® SureSight® Data CableAmbu A/SCCW2025-12-19
05707480164301Ambu® SureSight® Battery ChargerAmbu A/SCCW2025-12-19
09348811110183INKAThe Trustee for KAISER FAMILY TRUSTCCW2025-11-25
10884521849761McGRATH MAC+Covidien LPCCW2025-11-17
00198506085727ELMED INCORPORATEDELMED INCORPORATEDCCW2025-09-19
04250676716095Surgical laryngoscopeSpiggle & Theis Medizintechnik GmbHCCW2025-09-19
04250381858431Laser laryngoscope, size 1, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858448Laser laryngoscope, size 2, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858455Laser laryngoscope, size 3, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858462Laser laryngoscope, size 4, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858479Laser laryngoscope, size 5, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858486Laser laryngoscope, size 6, black, forSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858493Laser laryngoscope, size 7, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250676739933Holinger laryngoscopeSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250676741646Laser laryngoscope, Ulm typeSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250676741660Smoke evacuation tubeSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
00840183530662BR Surgical, LLCBR Surgical, LLCCCW2025-08-21
20197344135667MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135834MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135919MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135933MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135964MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135971MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14