FDA.reportPublic FDA data

Sensorendo

Primary DI
06974723790033
Brand
Sensorendo
Company
Sensorendo Medical Technology (Zhuhai) Co., Ltd.
Model
S-VLB
Device description
S-VLB Laryngoscope Disposable blade
Published
2024-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974723790033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974723790033069747237900336974723790033

GMDN Terms#

Term, Definition table
TermDefinition
Video intubation laryngoscope bladeA rigid, blade-like component of a bladed video intubation laryngoscope intended to be inserted into the oral cavity 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 an electronic camera at its distal end to transmit anatomical images by a video system to a connected video intubation laryngoscope handle/monitor. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8613602561980min@sensorendo.com

Regulatory Flags#

DUNS number
722337994
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974723795953SensorendoDP102023-12-27
16974723795950SensorendoDP102023-12-27
06974723796011SensorendoS-DVL2023-12-14
06974723790026SensorendoS-VLB2023-01-17
06974723791115SensorendoS-RVL2022-11-11
06974723792112SensorendoS-VL-012022-11-11
06974723793119SensornedoS-VL-R2022-11-11
06974723794413SensorendoS-FVL2022-11-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776426637MillenniumAvalign Technologies, Inc.LRC2026-08-19
00190776426347MillenniumAvalign Technologies, Inc.LRC2026-08-18
00844505014786FEATHERVAC, ECLIPSEGrace Medical, Inc.LRC2026-08-18
00844505014793FEATHERVAC, ECLIPSE FLAT RIBBONGrace Medical, Inc.LRC2026-08-18
04054462901142evonosevonos GmbH & Co. KGLRC2026-08-18
04054462901159evonosevonos GmbH & Co. KGLRC2026-08-18
04054462901166evonosevonos GmbH & Co. KGLRC2026-08-18
04054462901180evonosevonos GmbH & Co. KGLRC2026-08-18
04054462902170evonosevonos GmbH & Co. KGLRC2026-08-18
04054462902187evonosevonos GmbH & Co. KGLRC2026-08-18
00190776423704MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776423711MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776423728MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776424374MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776424381MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776424398MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776422653MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422660MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422684MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422462MillenniumAvalign Technologies, Inc.LRC2026-07-31
00190776422523MillenniumAvalign Technologies, Inc.LRC2026-07-31
00190776422585MillenniumAvalign Technologies, Inc.LRC2026-07-31
09348811102645INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-07-31
09348811102669INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-07-31
00198506093593ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093777ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093807ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093814ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
B382SD9200321000Surgical DirectSurgical Direct, Inc.LRC2026-07-29
B382SD9200321060Surgical DirectSurgical Direct, Inc.LRC2026-07-29