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The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices.
The products has several models. Different models are distinguished by needle gauge and length.
The Safety Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication.
The product is designed to reduce occurrence of accidental needle sticks from patient end of the needle by
providing a shield that covers and locks the needle after use. As the user proceeds with inserting the
needle into the skin the shield will retract. After the injection is completed and needle is removed
from the skin, the shield will automatically extend to cover the needle and lock in place. Once the
Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used.
The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected
devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
SPN-30-8
In Commercial Distribution
- 56971227400371 ()
- 36971227400377 ()
- 16971227400373 ()
- Autoinjector needle
SERUM DRUG SCREEN LEVEL 5
UTAK LABORATORIES, INC.
DS 5 S ID
In Commercial Distribution
- B800DS5SID5 ()
- B800DS5SID0 ()
- Total Volume: 3 Milliliter
DS 5 S ID
- Benzodiazepine group IVD, control
SERUM DRUG SCREEN LEVEL 4
UTAK LABORATORIES, INC.
DS 4 S ID
In Commercial Distribution
- B800DS4SID5 ()
- B800DS4SID0 ()
- Total Volume: 3 Milliliter
DS 4 S ID
- Benzodiazepine group IVD, control
SERUM DRUG SCREEN LEVEL 3
UTAK LABORATORIES, INC.
DS 3 S ID
In Commercial Distribution
- B800DS3SID5 ()
- B800DS3SID0 ()
- Total Volume: 3 Milliliter
DS 3 S ID
- Benzodiazepine group IVD, control
SERUM DRUG SCREEN LEVEL 2
UTAK LABORATORIES, INC.
DS 2 S ID
In Commercial Distribution
- B800DS2SID0 ()
- B800DS2SID5 ()
- Total Volume: 3 Milliliter
DS 2 S ID
- Benzodiazepine group IVD, control
SERUM DRUG SCREEN LEVEL 1
UTAK LABORATORIES, INC.
DS 1 S ID
In Commercial Distribution
- B800DS1SID0 ()
- B800DS1SID5 ()
- Total Volume: 3 Milliliter
DS 1 S ID
- Benzodiazepine group IVD, control
Working Tube Shaft, Standard Lip, iLESSYS DELTA
Joimax GmbH
WTS901300
In Commercial Distribution
- 04250337110385 ()
- L 91mm /ID 10.2mm /OD 13.7mm, radiolucent
WTS901300
- Endoscope sheath, reusable
Working Tube Shaft, straight 90°, iLESSYS DELTA
Joimax GmbH
WTS901304
In Commercial Distribution
- 04250337110422 ()
- L 91mm /ID 10.2mm /OD 13.7mm, radiolucent
WTS901304
- Endoscope sheath, reusable
Shaft for Nucleoscope
Joimax GmbH
PSD4030246
In Commercial Distribution
- 04250337109693 ()
- OD 4.0 mm / ID 3.6 mm / 45°
PSD4030246
- Endoscope sheath, reusable
The W-ADP software is an online platform to monitor Zeus V1 hand, monitor the usage of the device for the purpose of the settings and includes module to remotely connect with the patient.
AETHER BIOMEDICAL SP Z O O
W-ADP
In Commercial Distribution
- 05904569152253 ()
- Virtual-display rehabilitation system, powered-support, upper-limb